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Factors Influencing Flu Vaccination in Primary Health Care (FIVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04097197
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Information provided by (Responsible Party):
Frederico Rosário, Agrupamento de Centros de Saúde de Dão Lafões

Brief Summary:
This study aims to study the barriers to flu vaccination among at-risk people at the Primary Health Care level in order to increase the vaccination rates as recommended by the World Health Organization.

Condition or disease Intervention/treatment Phase
Flu, Human Behavioral: Brief educational intervention Not Applicable

Detailed Description:

People from vulnerable groups (e.g., those diagnosed with Diabetes, Chronic Obstructive Pulmonary Disease, Asthma) are at increased risk of developing complications from infection with influenza virus, that could ultimately result in death.

Flu vaccination is recommended by many authorities, including the World Health Organization, as a means to decrease the risk of developing such life-threatening conditions. However, vaccination rates are well below the recommended threshold.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 401 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Before-after study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Factors Influencing Flu Vaccination in Primary Health Care
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Patients receiving information
Patients in the experimental arm will receive a brief educational intervention if they initially refuse flu vaccination. The intervention was designed towards the most common barriers to flu vaccination that were found after a brief review of the literature. After the intervention, patients will be asked again whether or not they wish to receive the flu vaccine.
Behavioral: Brief educational intervention
same as before

Primary Outcome Measures :
  1. Flu vaccination refusal rate [ Time Frame: up to 6 months ]
    Percentage of patients refusing flu vaccination prior to intervention

Secondary Outcome Measures :
  1. Prevalence of barriers to flu vaccination [ Time Frame: up to 6 months ]
    Percentage of participants mentioning a determined barrier to flu vaccination

  2. Flu vaccination acceptance rate post-intervention [ Time Frame: up to 6 months ]
    Percentage of patients who accept receiving the flu vaccine after receiving the intervention

  3. Flu vaccination rate [ Time Frame: up to 6 months ]
    Percentage of patients who have been vaccinated after the intervention

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • People 65+ otherwise healthy;
  • Patients of any age diagnosed with at least one of the following conditions: Diabetes, Asthma, COPD, Coronary Disease or Hearth failure;
  • No history of flu vaccination in the previous year.

Exclusion Criteria:

  • Patients who have been vaccinated against the flu but who have no record of it in the clinical records;
  • Patients with contraindications to flu vaccination;
  • Patients that cannot be reached either by phone or letter.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04097197

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Contact: Frederico Rosário, Dr. +351232419900 ext 3237

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Dão Lafões Grouping of Primary Health Care Centres Not yet recruiting
Viseu, Dão Lafões, Portugal, 3514-511
Contact: Frederico M Rosário, MD    +351232419900 ext 3237   
Principal Investigator: Liliana Martins, Masters         
Sponsors and Collaborators
Agrupamento de Centros de Saúde de Dão Lafões

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Responsible Party: Frederico Rosário, Head of Research Department, Agrupamento de Centros de Saúde de Dão Lafões Identifier: NCT04097197     History of Changes
Other Study ID Numbers: FIVA_2019
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Frederico Rosário, Agrupamento de Centros de Saúde de Dão Lafões:
Influenza Vaccines
Influenza, Human
Primary Health Care
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs